Cellular immunotherapy licensed for advanced prostate cancer

Abstract

FDA on April 29 approved sipuleucel- T, or Provenge, for the treatment of asymptomatic or minimally symptomatic metastatic prostate cancer that is resistant to standard hormonal therapy. Officials at Seattle-based Dendreon said the company will make Provenge available to oncologists and urologists at about 50 sites that participated in clinical trials of the autologous cellular immunotherapy product. The company expects to make enough of the product this year to treat about 2000 patients, with additional capacity expected after new manufacturing facilities earn FDA licensure. Sipuleucel-T is designed to prime the patient’s own immune cells to attack prostate cancer cells, according to the company. The FDA-approved labeling for sipuleucel-T describes it as autologous peripheral blood mononuclear cells (PBMCs) collected by leukapheresis and cultured with prostatic acid phosphatase conjugated to granulocyte–macrophage colony-stimulating factor. The activated, prostate-antigen-targeting PBMCs and a residual amount of conjugate are then intravenously infused back into the patient. Each dose of the cellular immunotherapy product contains at least 50 million activated CD54+ PBMCs suspended in 50 mL of Lactated Ringer’s Injection, USP. A full treatment course consists of three infusions spaced approximately two weeks apart. Collection of the PBMCs occurs about three days before the scheduled infusion of each finished dose.